Battery Certification For
Medical Devices
Rich Byczek, 7/31/2013
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Agenda
• IEC 62133 adoption, transition
• Certification options for Lithium Batteries
• End product requirements and application
• Transportation requirements for Lithium Batteries
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Battery Standards Arena
US- Based Standards:
UL-1642: Lithium Batteries
- Focus on single-cells
- Used for evaluation of Lithium-Metal (PRIMARY)
- Used for evaluation of Lithium-Ion (SECONDARY)
UL-2054: Household and Commercial Batteries
- Focus on Portable Batteries
- Typically Battery Packs
- References UL 1642 for Lithium Cells
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Battery Standards Arena
IEC - Based Standards:
IEC-60086
- Primary Batteries (Non-rechargeable)
- Covers Performance and Safety
- IEC-60086-4 For Lithium (Primary) battery safety
IEC-62133
- Secondary Batteries (Rechargeable)
- Focus on Lithium-ion Batteries
- First Edition, October 2002
- Second Edition released: December 2012
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IEC 62133 Adoption, Transition
NORTH AMERICAN NRTL CERTIFICATIONS:
- May still use UL 1642/ UL 2054 for cells and packs, as
acceptable US-based component standards.
- Applies to Lithium and Lithium-ion chemistries
- Applies to Nickel Metal Hydride and Nickel Cadmium
chemistries
- Verify with NRTL if they will allow usage of batteries and cells
certified to IEC standards (such as IECEE CB Scheme)
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IEC 62133 Adoption, Transition
IECEE CB SCHEME:
TRANSITION TESTING IS NO LONGER VALID OPTION
Since May 2012:
- Batteries tested to UL 1642 or UL 2054 will not be accepted
for CB Scheme Certificates
- Rechargable Batteries and cells must be CB Scheme
certified to IEC 62133
- Non-Rechargable Lithium Batteries and cells must be CB
Scheme certified to IEC 60086-4 (specified in IEC 60601-1)
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IEC 62133 Adoption, Transition
Who is affected by this regulatory change?
Portable Battery
IEC 62133
Medical Devices
Powertools
IEC60601
IEC60745
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Household App
IEC60335
Other (Except
Telecom and A/V)
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IEC 62133 Adoption, Transition
Who is NOT affected by this regulatory
change?
Portable Battery
Use UL
standards
Audio Video
IEC60065
ICT
IEC60950
NOTE: TC 108 still accepts UL 1642 and UL 2054 for CB Scheme
certification
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IEC 62133 Adoption, Transition
IEC 62133 2nd Edition
Released December 2012
Added to IECEE CB Scheme in Q1, 2013
EU adopted as EN 62133 2nd edition
Date of Withdrawal : 1/10/2016
- Majority of changes are for Lithium Ion cells.
- Lithium Ion Battery packs have minimal changes
- Nickel Batteries(NiMH and NiCD): almost no change
- Verify national deviations for other standards (such as IEC/UL
60950-1), which may specify other standards
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IEC 62133 Adoption, Transition
NORTH AMERICAN NRTL CERTIFICATIONS:
- May still use UL 1642/ UL 2054 for cells and packs, as
acceptable US-based component standards.
- Applies to Lithium and Lithium-ion chemistries
- Applies to Nickel Metal Hydride and Nickel Cadmium
chemistries
- Verify with NRTL if they will allow usage of batteries and cells
certified to IEC standards (such as IECEE CB Scheme)
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Transportation Requirements
Transportation Test requirements are required
for all Lithium and Lithium-Ion cells and
batteries!
-
Self Declaration
Global requirement
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Transportation Requirements
LATEST and GREATEST UN MANUAL:
Recommendations on the Transport of Dangerous
Goods. Manual of Tests and Criteria.
5th Revised Edition, amendment 1 (2011)
Section 38.3 refers to “Lithium Battery Testing
Requirements”
Per Federal register 49 CFR sections 171.7
- 5th Ed. Rev 1 since January 2013
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Transportation Requirements
T1: Altitude Simulation: Simulated
50,000ft/15,000m cargo
T2: Thermal Test: Simulated min/max
temperature extremes
T3: Vibration: Sine sweep-style vibration scan
T4: Shock: Simulation of severe drop and impact
T5: External Short Circuit
T6: Impact/Crush (Cells Only): simulated crush
and internal short circuit
T7: Overcharge (Rechargeable Batteries Only):
incorrect chargers used in the field.
T8: Forced Discharge (Cells): Simulates user
error/incorrect installation
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UN Manual of Tests and Criteria
Samples Needed: SECONDARY BATTERIES (5th edition)
SMALL BATTERY:
Gross Mass up to 12 kg
LARGE BATTERY:
Gross Mass over 12 kg
1st Cycle
CHARGED
25 Cycle CHARGED
TOTAL
Small
Batteries
8
8 (50 cycles)
16
Large
Batteries
4
4 (25 cycles)
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NOTE: Sample quantity may be cut in half, but client needs to know
IF SAMPLES CAN BE RE-USED AFTER SHORT CIRCUIT TEST
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UN Manual of Tests and Criteria
Samples Needed: Very large batteries or “Battery Assemblies”
-
Lithium Ion Rechargeable Packs
-Up to 6,200 Wh rating
-Cells/ Modules already tested
-1 (or 2) sample(s) only, cycled 25 times,
fully charged
-Tests 3,4,5 and 7 only
-
More than 500g Lithium or 6,200 Wh Rating
-No testing required if BMS (Battery
Management System) in place.
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Thank You.
Rich Byczek
Global Technical Lead, EV and
Energy Storage
248-219-1099
[email protected]
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